The medicinal cannabis industry is experiencing unprecedented growth, with projections estimating its global market value to reach $50 billion by 2030. This surge is largely attributed to the widespread legalisation of cannabis for medical purposes across various jurisdictions. But as the industry expands, ensuring that products meet stringent quality standards remains a significant challenge. Beccy Bell, Associate Director of Laboratory Services at testing and regulatory consultancy Broughton, discusses how in-process testing can help producers meet the escalating demand while maintaining product integrity.
In-process testing involves routine checks during the production process, where samples are analysed to assess their THC or CBD content. This approach allows producers to monitor and maintain the desired cannabinoid profiles, ensuring consistency and quality in the final product. Bell emphasises that as the market grows, medicinal cannabis producers face increasing pressure to deliver high-quality products within strict timelines. Challenges such as variability in cannabinoid content, inefficiencies in testing processes, and delays in receiving actionable data can adversely impact workflows, profitability, and market entry.
Cannabis remains a Schedule 1 controlled substance in many regions, subjecting it to enhanced controls and restricting handling to facilities with the appropriate licences. In the UK, for instance, the British Pharmacopoeia set forth rigorous quality standards in July 2024, which producers must adhere to. However, the limited number of authorised facilities capable of handling Schedule 1 substances poses a bottleneck in the testing process. Bell notes that while in-process testing typically involves a reduced suite of analyses, it can detect unexpected changes in the cannabis flower, providing a quality control check within a shorter timeframe.
To address these challenges, Bell suggests that growers collaborate closely with Contract Research Organisations (CROs) for in-process testing. Such partnerships require transparency in sample preparation and testing protocols to ensure a smooth and efficient process. Growers with in-house laboratory capabilities must establish a clear plan during harvesting. The CRO assesses its ability to meet the target concentrations set by the grower, involving the sharing of dried flower preparation instructions to initiate extraction, which are then sent to the CRO for analysis.
This collaborative process facilitates regular testing throughout the growth cycle, aiding in determining the optimal harvest time and reducing production downtime. Bell highlights that demonstrating the repeatability and reproducibility of the extraction process is crucial, akin to the acceptance criteria used in pharmaceutical analytical method transfers.
As the medicinal cannabis market continues to evolve, the focus is expanding beyond plant material to include extracts, oils, and finished products. Companies like Broughton are positioning themselves as innovation partners in this progression. With in-process testing services and the necessary licences, combined with familiarity with pharmacopoeial standards and years of Good Manufacturing Practice (GMP) compliance, Broughton enables customers to receive THC and CBD level analyses within 48 hours. This rapid turnaround allows growers to make swift decisions regarding their cultivation processes.
The rapid expansion of the medicinal cannabis industry necessitates robust quality control measures to ensure product safety and efficacy. In-process testing, facilitated through strategic collaborations between growers and CROs, offers a viable solution to meet market demands without compromising on quality. As the industry matures, such partnerships and processes will be integral in maintaining the delicate balance between growth and regulation.
